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Package Leaflet: Information for the User Package leaflet: Information for the user Livial® 2.5 mg tablets TIBOLONE Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. In this leaflet: 1. What Livial is and what it is used for 2. What you need to know before you take Livial 3. How to take Livial 4. Possible side effects 5. How to store Livial 6. Contents of the pack and other information 1. What Livial is and what it is used for Livial 2.5 mg tablet The active substance is: tibolone. This medicine is a hormone replacement therapy (HRT). It contains tibolone, a substance that has favourable effects on different tissues in the body, such as brain, vagina and bone. This medicine is used in postmenopausal women with at least 12 months (1 year) since their last natural period. This medicine is used for: Relief of symptoms occurring after menopause During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Livial alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life. Prevention of osteoporosis After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Livial to prevent osteoporosis after menopause. There are three different kinds of HRT: • Oestrogen-only HRT • Combined HRT, containing two kinds of female hormone, an oestrogen and a progestogen. • Livial, which contains a substance called tibolone Livial is different from other HRT. Instead of actual hormones (such as oestrogen and progestogen) it contains tibolone. Your body breaks down tibolone to make hormones. Its effects and benefits are similar to combined HRT. In section 6, ‘Contents of the pack and other information’ you can find more information about Livial and what it is used for. 2. What you need to know before you take Livial For information on when you can start taking Livial, (including after a hysterectomy) see section 3.1 (overleaf). Medical History and regular check-ups The use of HRT or Livial carries risks that need to be considered when deciding whether to start taking it, or whether to carry on taking it. This is especially important if you are more than 60 years old. The experience in treating women with a premature menopause (due to ovarian failure or surgery) is limited. If you have a premature menopause the risks of using HRT or Livial may be different. Please talk to your doctor. Before you start taking or restart HRT or Livial Your doctor will ask about your own and your family’s medical history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and /or an internal examination, if necessary. →Tell your doctor if you have any medical problems or illnesses. Regular check-ups Once you have started on Livial, you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Livial. Go for regular breast screening, as recommended by your doctor. Be sure to • go for regular breast screening and cervical smear tests • regularly check your breasts for any changes such as dimpling of the skin, changes in the nipple, or any lumps you can see or feel. 2.1 Some women should not take Livial Do not take Livial If any of the following applies to you. If you are not sure about any of the points below, talk to your doctor before taking Livial • If you have or have ever had breast cancer, or if you are suspected of having it • If you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it • If you have any unexplained vaginal bleeding • If you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated. • If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) • If you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) • If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina • If you have or have ever had a liver disease and your liver function tests have not returned to normal • If you have a rare blood problem called “porphyria” which is passed down in families (inherited) • If you are allergic to tibolone or any of the other ingredients of this medicine (listed in section 6) • If you are pregnant or think you might be pregnant. • If you are breastfeeding. If any of the above conditions appear for the first time while taking Livial, stop taking it at once and consult your doctor immediately. If you have started the menopause you should not take Livial until 12 months after your last natural period. If you take it sooner than this you may have irregular bleeding. 2.2 Warning and precautions Talk to your doctor, pharmacist or nurse before taking Livial. If you have ever had any of the following problems, tell your doctor before you start the treatment, as these may return or become worse during treatment with Livial. If so, you should see your doctor more often for check-ups: • fibroids inside your womb • growth of the womb lining outside your womb (endometriosis) or a history of excessive growth of the womb lining (endometrial hyperplasia) • increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”) • increased risk of getting an oestrogen-sensitive cancer (such as having a mother, sister or grandmother who has had breast cancer) • high blood pressure • a liver disorder, such as a benign liver tumour • diabetes • gallstones • migraine or severe headaches • a disease of the immune system that affects many organs of the body (systemic lupus erythematosus, SLE) • epilepsy • asthma • a disease affecting the eardrum and hearing (otosclerosis) • a very high level of fat in your blood (triglycerides) • fluid retention due to cardiac or kidney problems 2.3 Stop taking Livial and see a doctor immediately If you notice any of the following when taking Livial: • any of the conditions mentioned in the "Do not take Livial" section • yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease • a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness) • migraine-like headaches which happen for the first time • if you become pregnant • if you notice signs of a blood clot, such as: − painful swelling and redness of the legs − sudden chest pain − difficulty in breathing For more information, see “Blood clots in a vein (thrombosis)”. Note: Livial is not a contraceptive. If it is less than 12 months since your last menstrual period or you are under 50 years old, you may still need to use additional contraception to prevent pregnancy. Speak to your doctor for advice. 2.4 HRT and Cancer Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer of the lining of the womb (endometrial cancer) There have been reports of an increased cell growth or cancer of the lining of the womb in women using Livial. The risk of cancer of the lining of the womb increases the longer you take the medicine. Irregular bleeding You may have irregular bleeding or drops of blood (spotting) during the first 3-6 months of taking Livial. But if the bleeding or spotting: • Carries on for more than the first 6 months • Starts after you have been taking Livial for more than 6 months • Carries on even after you’ve stopped taking Livial →see your doctor as soon as possible. Breast cancer Evidence shows that taking tibolone increases the risk of breast cancer. The extra risk depends on how long you use tibolone. In studies with HRT, after stopping HRT the extra risk decreased with time, but the risk may persist for 10 years or more when women have used HRT for more than 5 years. No data for persistence of risk after stopping are available for tibolone, but a similar pattern cannot be ruled out. Compare Women taking Livial have a lower risk than women using combined HRT and a comparable risk with oestrogen-only HRT. • Regularly check your breasts. See your doctor if you notice any changes such as: o dimpling or sinking of the skin o changes in the nipple o any lumps you can see or feel →Make an appointment to see your doctor as soon as possible Ovarian cancer Ovarian cancer is rare – much rarer than breast cancer. The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.
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